Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1BIOPHORE INDIA PHARMACEUTICALS PVT. LTD. Hyderabad IN
02 1AGC PHARMA CHEMICALS EUROPE S.L.U. Malgrat De Mar ES
03 1ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN
04 1HETERO DRUGS LIMITED Hyderabad IN
01 4Mexiletine hydrochloride
01 4India
01 4Valid
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Certificate Number : R0-CEP 2020-384 - Rev 00
Status : Valid
Issue Date : 2022-05-17
Type : Chemical
Substance Number : 1029
Certificate Number : CEP 2017-107 - Rev 03
Status : Valid
Issue Date : 2024-04-05
Type : Chemical
Substance Number : 1029
Certificate Number : R1-CEP 2014-057 - Rev 01
Status : Valid
Issue Date : 2021-01-11
Type : Chemical
Substance Number : 1029
Certificate Number : R0-CEP 2021-421 - Rev 00
Status : Valid
Issue Date : 2023-03-10
Type : Chemical
Substance Number : 1029
A Mexiletine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mexiletine, including repackagers and relabelers. The FDA regulates Mexiletine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mexiletine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Mexiletine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mexiletine supplier is an individual or a company that provides Mexiletine active pharmaceutical ingredient (API) or Mexiletine finished formulations upon request. The Mexiletine suppliers may include Mexiletine API manufacturers, exporters, distributors and traders.
click here to find a list of Mexiletine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mexiletine CEP of the European Pharmacopoeia monograph is often referred to as a Mexiletine Certificate of Suitability (COS). The purpose of a Mexiletine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mexiletine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mexiletine to their clients by showing that a Mexiletine CEP has been issued for it. The manufacturer submits a Mexiletine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mexiletine CEP holder for the record. Additionally, the data presented in the Mexiletine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mexiletine DMF.
A Mexiletine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mexiletine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Mexiletine suppliers with CEP (COS) on PharmaCompass.
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